Contrast Enhancement in Magnetic Resonance Imaging, Healthy Volunteers
Conditions
Keywords
Safety, Pharmacokinetics
Brief summary
The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Chinese healthy male participants: * the safety of BAY1747846 when given at increasing single doses * the level of BAY1747846 in the blood over time when given at increasing single doses. To answer the first question, the researchers compared the number and severity of medical problems the Chinese participants had after receiving BAY1747846 at increasing doses and placebo respectively. Doctors kept tracking of all medical problems that happened in the study, even if they did not think they might be related to the study treatments. To answer the second question, the researchers determined: * the (average) total level of BAY1747846 in the blood, also called AUC * the (average) highest level of BAY1747846 in the blood, also called Cmax * how BAY1747846 is removed from the blood, also called clearance (CL).
Interventions
DRUGGadoquatrane (BAY1747846) 0.03 mmol Gd/kg
0.03 mmol Gd/kg by intravenous injection (at 2 mL/s)
DRUGGadoquatrane (BAY1747846) 0.1 mmol Gd/kg
0.1 mmol Gd/kg by intravenous injection (at 2 mL/s)
DRUGMatching placebo
0.9% sodium chloride by intravenous injection (at 2 mL/s)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
Parallel-group, consecutive cohort, escalating single-dose study design
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent prior to any study specific tests or procedures * Chinese male between 18 and 45 years (inclusive) at screening visit * Body mass index (BMI): 18.5 to 30.0 kg/m² (inclusive) * Body weight (bw): 50 to 90 kg (inclusive) * Participants of reproductive potential must agree to use adequate contraception whenever having sexual intercourse with a woman of child-bearing potential. This applies for the time period from signing of the ICF to at least 1 week after treatment. The definition of adequate contraception will be based on the judgment of the investigator and on local requirements * Healthy, based on medical history, physical examination, electrocardiography (ECG), and laboratory tests
Exclusion criteria
* Use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (only use of contraceptives and occasional use of paracetamol, aspirin or ibuprofen is permissible) * Any severe disease within the last 4 weeks prior to the first study drug administration * Any clinically relevant finding at the physical examination and chest X ray (posterior-anterior) examination * Any clinically relevant deviation from reference ranges of the laboratory parameters at screening or alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin exceeding the upper limit of normal range (ULN) by more than 10%, or creatinine above the ULN, or hemoglobin below 12 g/dL * Vital signs: Pulse rate \<50 or \>90beats/min, Systolic blood pressure \<100 or ≥140 mmHg, Diastolic blood pressure \<60 or ≥90 mmHg, or other abnormal vital signs * Any known disposition for allergic, anaphylactoid, hypersensitivity or idiosyncratic reactions, e.g. any history of clinical signs of hypersensitivity reaction to any agent (including, but not limited to, any allergen, food, drug, chemical, or contrast agent) * Family history of hypersensitivity reaction to contrast agent * Regular alcohol consumption equivalent to \>20 g alcohol per day within 3 months prior to screening * Smokers who smoke more than 5 cigarettes per day within 3 months prior to screening and/or who cannot refrain from smoking from screening until the end of hospitalization * Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAE) | From drug administration up to 7 days after end of test drug administration (from day 1 to day 8) | Including severity of TEAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Pre-dose, on Day 1, Day 2, Day 3 and Day 4 | Cmax: Maximum observed drug concentration in measured matrix after single dose administration |
| AUC | Pre-dose, on Day 1, Day 2, Day 3 and Day 4 | AUC: Area under the concentration vs. time curve from zero to infinity after single dose in case AUC cannot be determined reliably for all participants, AUC will be replaced by AUC(0-tlast) |
| CL | Pre-dose, on Day 1, Day 2, Day 3 and Day 4 | CL: Total body clearance of drug |
| CL/bw | Pre-dose, on Day 1, Day 2, Day 3 and Day 4. | CL/bw: Total body clearance of drug normalized by body weight |
Countries
China
Outcome results
None listed